KARL STORZ Holders

K240506 · Karl Storz Endoscopy America, Inc. · OCV · Oct 22, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K240506
• Device Name: KARL STORZ Holders
• Applicant: Karl Storz Endoscopy America, Inc.
• Product Code: OCV · Gastroenterology, Urology
• Decision Date: Oct 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.

Device Story

Manually operated surgical instrument; holds endoscopes and accessories in desired position during diagnostic, therapeutic, and neurologic procedures. Device consists of stainless steel holder; user manually tightens or loosens knob to open/close clamp around scope. Attaches to KARL STORZ holding systems (table-mounted mechanical/electromechanical arms). Used in surgical settings by clinicians. Provides stable positioning of scopes; reduces manual fatigue for surgeon; facilitates visualization during procedures.

Clinical Evidence

Bench testing only. Testing included holding performance and direction of view/image stability testing.

Technological Characteristics

Material: Stainless steel. Operation: Manual (knob-actuated clamp). Dimensions: Supports scope diameters up to 23mm. Load capacity: 3kg. Connectivity: None (mechanical attachment to holding arms). Sterilization: Steam sterilization.

Indications for Use

Indicated for patients undergoing general and neurologic diagnostic and therapeutic procedures requiring the use of endoscopes or surgical accessories.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Walterlorenz Surgical Assist Arm Scope Holder (K190576)

Submission Summary (Full Text)

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October 22, 2024

KARL STORZ Endoscopy America, Inc Mario Trujillo Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245

Re: K240506

Trade/Device Name: KARL STORZ Holders Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCV, GCJ Dated: September 23, 2024 Received: September 23, 2024

Dear Mario Trujillo:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

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Sincerely,

Digitally signed by Long H. Long H. Chen -Chen -S S Date: 2024.10.22 13:32:12 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K240506

Device Name

KARL STORZ Holders

Indications for Use (Describe)

The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/4/Picture/0 description: The image is a logo for STORZ. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The logo is simple and professional.

## 510(k) Summary

This 510(i) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.

| Submitter: | KARL STORZ SE & Co. KG<br>Dr.-Karl-Storz-Straße 34<br>78532 Tuttlingen, Germany | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo<br>Regulatory Affairs Specialist<br>Tel.: [phone]<br>Email : [e-mail] | | |
| Date of<br>Preparation: | October 21, 2024 | | |
| Device<br>Identification: | Trade Name: KARL STORZ Holders<br>Common Name: Endoscope Holder<br>Classification Name: Endoscope Holder (21 CFR Part 876.1500); | | |
| Regulatory<br>Class: | 2 | | |
| Product Code: | Primary: OCV<br>Secondary: GCJ | | |
| Predicate<br>Devices: | Walterlorenz Surgical Assist Arm Scope Holder (K190576) | | |
| Device<br>Description: | The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes,<br>arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic<br>procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a<br>knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding<br>systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general<br>surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning. | | |
| Indications For<br>Use: | The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc)<br>and accessories during general and neurologic diagnostic and therapeutic procedures. | | |
| Substantial<br>equivalence | The similarities of the subject device to the predicate devices are as follows: | | |
| | | Subject Device – K240506<br>KARL STORZ Holders | Predicate Device - K190576<br>WalterLorenz Surgical Assist Arm Scope<br>Holder |
| | Indications for Use | The KARL STORZ Holders are manually<br>operated surgical devices intended to hold<br>endoscopes (such as arthroscopes, etc)<br>and accessories during general and<br>neurologic diagnostic and therapeutic<br>procedures. | The WalterLorenz Surgical Assist Arm Scope<br>Holder is a manually operated surgical device<br>intended to hold scopes (such as endoscopes,<br>arthroscopes, etc) and accessories during<br>general diagnostic and therapeutic procedures.<br>The device is also intended to hold<br>endoscopes during diagnostic and therapeutic<br>neurologic procedures. |
| | Material of construction | Stainless Steel | Stainless Steel |
| | Devices to be held | Endoscopes and other surgical instruments | Endoscopes and other surgical instruments |
| | Mode of operation | Manual | Same as subject device |
| | Range of scope diameters | Up to 23mm | Up to 10mm |
| | Scratch Protection pads | Yes | No |
| | Maximum loading weight | 3kg | Information not available |
| | Cleaning | Manual cleaning | Manual cleaning |
| | Sterilization/ Reprocessing<br>Methods | Steam Sterilization | Steam Sterilization |
| Non-Clinical<br>Performance<br>Data: | The following non-clinical testing were performed on the subject device:<br>1) Holding Performance testing<br>2) Direction of view/Image stability testing | | |